Medicinal Product Support in Bahrain
End-to-end Regulatory support from experienced professionals.

Medicinal Products Regulatory Support in Bahrain – Overview

Bahrain’s pharmaceutical market is strategically important within the GCC region, with regulation centralized under the National Health Regulatory Authority (NHRA), established to ensure the quality, safety, and efficacy of medicines. Registration requires licensed MAH/agent representation, compliance with pharmaceutical data standards aligned with GCC and ICH, eCTD dossiers, GMP compliance, and local pricing submissions. The NHRA also operates advanced digital platforms such as ADWEYA for online submissions, renewals, variations, and agency transfers.

Freyr Solutions enables life sciences companies to navigate every stage of the Regulatory journey from strategy and dossier compilation to submission management and authority engagement, ensuring timely, compliant access to the Bahraini market.

Medicinal Product Classification in Bahrain

Medicinal products in Bahrain must be classified before Regulatory action. NHRA guidelines categorize products broadly, influencing how they are registered, dispensed, and controlled. Classification examples (based on NHRA practices and GCC standards) include:

1. Prescription‑Only Medicines (POM)
   Medicines that require a valid medical prescription.
2. Pharmacy‑Only (P)
   Medicines are supplied under the supervision of a pharmacist without a prescription.
3. General Sale (GS)
   Low-risk medicines are available in general retail outlets.
4. Biological Drug Products: Includes vaccines, blood products, biosimilars, recombinant proteins, etc.

Additional Categories (aligned with pharmaceutical framework & market practices):

• Herbal / Traditional Products: often categorized separately under health products.
• Combination Products: drugs combined with devices or novel components.
• Health Products / Supplements: vitamins, minerals, and nutraceutical products not classified strictly as medicines.
• Alternative and Complementary Medicines: Covers homeopathy, ayurveda, and other non-mainstream modalities; differentiated based on claims and composition.

Medicinal Product Registration & Approval in Bahrain

The NHRA oversees the licensing and regulation of all pharmaceutical products. Key steps include

1. Classification / Pre-assessment
   Determine the Regulatory pathway based on product definition and classification guidelines.
2. Local MAH & Agent Licensing
   The Marketing Authorization Holder (MAH) and agent must be licensed with the NHRA; importation is only via licensed entities.
3. Dossier Submission
   Submit an eCTD-formatted dossier covering quality, safety, and efficacy, along with certificates (CPP, GMP) and labeling data.
4. NHRA Technical Review
   The NHRA evaluates the submission; additional information or clarifications may be sought.
5. Issuance of License/Registration
   Upon approval, a product license is issued (usually valid for five years).
6. Renewals & Variations
   Products must be renewed before expiry; any changes (formulation, site, labeling) require NHRA approval.
7. Post‑Approval Obligations
   GMP compliance, batch release documentation, pharmacovigilance, and barcode/serialization compliance under NHRA traceability systems are mandatory.

Specific Pathways & Timelines:

• Fast‑Track Registration (10–20 days) for products with reference authority approvals (e.g., SFDA, FDA, EMA).
• Standard licensing may take longer depending on the product and the completeness of the dossier.